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IMMAGE® Immunochemistry Systems

Chemistry Information Sheet

|IGE

Total Immunoglobulin E

REF (150 tests) 474620 | |For In Vitro Diagnostic Use

ANNUAL REVIEW

|REVIEWED BY: |DATE |REVIEWED BY: |DATE |

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PRINCIPLE

INTENDED USE

IGE reagent, when used in conjunction with IMMAGE® Immunochemistry Systems and IGE Calibrator, is intended for quantitative determination of total immunoglobulin e (IGE) concentration in human serum or plasma by rate turbidimetry.

CLINICAL SIGNIFICANCE

IGE is a member of the immunoglobulin family of proteins that was first described in the 1960’s.1,2 IGE, like all immunoglobulins, is produced by plasma cells in response to antigenic stimuli. IGE is unique however in certain structural aspects and the role it plays in allergic diseases.

Measurement of total serum IgE is often used as a tool in the diagnosis and management of atopic diseases such as asthma, hay fever, atopic dermatitis and urticaria. It has been used to distinguish atopic from non-atopic individuals presenting allergy-like symptoms.3 In addition, studies have also shown that increased levels of IgE in cord blood and infants may be predictive of future atopic tendencies.4,5

Normal levels of circulating IgE are extremely low in comparison to other immunoglobulins. Levels of IgE at birth are almost undetectable but increase in non-allergic adults.6 Elevated levels are commonly seen in cases of allergic diseases, parasitic infections, pulmonary aspergillosis, Wiskott-Aldrich Syndrome, and myeloma.7,8,9,10,11

Serum IgE levels may vary as a result of diet, genetic background, geographical location and other factors. It is therefore recommended that total IgE measurements be used in conjunction with other clinical tests when establishing diagnoses.

METHODOLOGY

The IMMAGE IGE reagent is based on the sensitive Near Infrared Particle Immunoassay (NIPIA) rate methodology. An anti-IgE antibody-coated particle binds to IgE in the patient sample resulting in the formation of insoluble aggregates causing turbidity. The rate of aggregate formation is directly proportional to the concentration of IgE in the sample.

CHEMICAL REACTION SCHEME

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SPECIMEN

TYPE OF SPECIMEN

Serum samples are recommended. Plasma samples (EDTA, Lithium Heparin, and Sodium Heparin) can be used.

Serum or plasma samples should be collected in the manner routinely used for any clinical laboratory test.12 Freshly drawn serum or plasma from a fasting individual is preferred. Anticoagulants tested are listed in the PROCEDURAL NOTES section of this chemistry information sheet.

SPECIMEN STORAGE AND STABILITY

1.  Tubes of blood are to be kept closed at all times and in a vertical position. It is recommended that the serum or plasma be physically separated from contact with cells within two hours from the time of collection.13

2.  If serum samples are not assayed within 8 hours, the samples can be stored at +2°C to +8°C for up to 72 hours. Serum samples can be stored at -15°C to -20°C for up to 2 months if they are frozen within 24 hours of collection. Frozen samples should be thawed only once. Analyte deterioration may occur in samples that are repeatedly frozen and thawed.13

3.  Plasma samples can be stored at +2°C to +8°C for up to 72 hours. Plasma samples should not be frozen.

Additional specimen storage and stability conditions as designated by this laboratory:

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SAMPLE VOLUME

For sample volumes refer to the Sampling Template.

CRITERIA FOR UNACCEPTABLE SPECIMENS

Refer to the PROCEDURAL NOTES section of this chemistry information sheet.

Criteria for sample rejection as designated by this laboratory:

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PATIENT PREPARATION

Special instructions for patient preparation as designated by this laboratory:

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SPECIMEN HANDLING

Special instructions for specimen handling as designated by this laboratory:

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REAGENTS

CONTENTS

Each kit contains the following items:

|KIT COMPONENTS |QUANTITY |

| IGE Cartridge (Antibody and Reaction Buffer) | 3 |

| Evaporation Caps | 6 |

| IGE Calibrator, 2 mL | 1 |

| IGE Reagent Bar Code Card | 1 |

| IGE Calibrator Bar Code Card | 1 |

| IGE Calibrator Strips | 2 |

| Value Assignment Sheet | 1 |

INITIAL VOLUMES OF SAMPLE AND REAGENTS IN THE CUVETTE

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| | | 20 µL |

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| | | 242 µL |

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|  | Antibody-coated particle | 47 µL |

|  | Reaction Buffer | 140 µL |

|  | Diluent 1 | 55 µL |

REACTIVE INGREDIENTS

|REAGENT CARTRIDGE CONSTITUENTS |VOLUME |

| IgE Antibody (particle-bound mouse anti-IgE antibody) | 3.0 mL |

| Reaction Buffer | 7.7 mL |

| Sodium Azide (used as a preservative) | < 0.1% (w/w) |

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|CALIBRATOR CONSTITUENTS | |

| Human IgE (diluted in a non-serum matrix) | 2 mL |

| Sodium Azide (used as a preservative) | < 0.1% (w/w) |

| Bovine Serum Albumin (BSA) | 6.0% |

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[pic][pic]CAUTION

Sodium azide preservative may form explosive compounds in metal drain lines. See National Institute for Occupational Safety and Health Bulletin: Explosive Azide Hazards (8/16/76).

[pic][pic]CAUTION

Because this product is of human origin, it should be handled as though capable of transmitting infectious diseases. Each serum or plasma donor unit used in the preparation of this material was tested by United States Food and Drug Administration (FDA) approved methods and found to be negative for antibodies to HIV and HCV and nonreactive for HbsAg. Because no test method can offer complete assurance that HIV, hepatitis B virus, and hepatitis C virus or other infectious agents are absent, this material should be handled as though capable of transmitting infectious diseases. This product may also contain other human source material for which there is no approved test. The FDA recommends such samples to be handled as specified in Centers for Disease Control's Biosafety Level 2 guidelines.14

MATERIALS NEEDED BUT NOT SUPPLIED WITH REAGENT KIT

IMMAGE Immunochemistry Systems Wash Solution

IMMAGE Immunochemistry Systems Diluent 1

Centrifuge capable of 90,000 x g

At least two levels of control material

REAGENT PREPARATION

1.  Invert cartridge gently before removing screw caps.

2.  Remove screw caps from reagent cartridges. Check each cartridge for bubbles and remove any bubbles present.

3.  Place evaporation caps on both reagent cartridge compartments before loading the cartridge on the instrument. See Appendices for evaporation cap directions.

4.  Reagent cartridges should be stored upright and can be removed from the refrigerator and used immediately.

5.  Mix all buffers and diluents thoroughly by inversion. Remove screw cap from container. Check each container for bubbles and remove any bubbles present. Place evaporation cap on container before loading the container on the instrument. See Appendices for evaporation cap directions.

ACCEPTABLE REAGENT PERFORMANCE

Acceptability of a reagent is determined from the successful performance of quality control testing, as defined in the QUALITY CONTROL section of this chemistry information sheet.

REAGENT STORAGE AND STABILITY

Storage conditions other than those recommended may cause erroneous results.

Reagent Cartridges

1.  Return all reagent cartridges to the refrigerator (+2°C to +8°C) upon completion of the daily workload.

2.  The IGE reagents are stable for 14 days with the evaporation caps in place. Alternatively, reagent life can be maximized by replacing evaporation caps with screw caps and storing at +2°C to +8°C upon completion of the daily workload.

3.  The IGE reagents are stable until the expiration date on the label if the reagents are stored at +2°C to +8°C with the screw caps in place.

Diluent 1

1.  Diluent 1 is stable on the system for 30 days with the evaporation caps in place.

2.  Diluent 1 is stable until the expiration date on the label if stored at room temperature with the screw caps in place.

Reagent storage location:

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CALIBRATION

CALIBRATOR REQUIRED

IGE Calibrator (included in reagent kit)

CALIBRATOR PREPARATION

No preparation is required.

CALIBRATOR STORAGE AND STABILITY

The calibrator is stable until the expiration date printed on the calibrator bottle if stored capped in the original container at +2°C to +8°C.

Storage conditions other than those recommended may cause erroneous results.

Calibrator storage location:

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CALIBRATION INFORMATION

1.  The IMMAGE® Immunochemistry Systems calibration is reagent lot specific.

2.  The IGE reagent lot should be recalibrated following specific part replacements or maintenance procedures as defined in the IMMAGE Operations Manual.

3.  The IMMAGE Immunochemistry System is designed for minimum calibration. Calibrations retained in system memory should be monitored by the performance of quality control procedures on each day of testing.

4.  Calibration for IGE is stable for 30 days.

5.  The system will automatically perform a verification check during calibration and produce a calibration report. The system will alert the operator of a failed calibration. An explanation of any accompanying error message can be found in the TROUBLESHOOTING Section of the IMMAGE® Immunochemistry Systems Operations Manual.

6.  Calibration verification information can be found in the CALIBRATION VERIFICATION section of the IMMAGE® Immunochemistry Systems Chemistry Reference Manual.

CALIBRATOR ASSIGNED VALUES

The assigned value for IGE Calibrator was determined using a matrix of multiple instruments, runs and replicates. For calibrator assigned values, see the Value Assignment Sheet provided in the Reagent Kit.

CALIBRATOR SUMMARY

The IGE Calibrator is a preparation of human IgE serum diluted in a non-serum matrix containing BSA, salts and ................
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